Forbes columnist Steven Salzberg and author-investigator Joe Nickell will each be awarded the 2012 Robert P. Balles Prize in Critical Thinking, to be presented by the Committee for Skeptical Inquiry at the CFI Summit in October.

The HPV Vaccine Controversy

Shobha S. Krishnan

Ever since the FDA approved the human papillomavirus (HPV) vaccine in 2006, its introduction has been embroiled in a medical, social, cultural, and
political controversy. This controversy has once again been rekindled in the recent Republican primary debates between Texas governor Rick Perry and
Congresswoman Michele Bachmann from Minnesota, in which Bachmann emphatically stated that Merck's HPV vaccine, Gardasil, causes mental retardation.

As a physician, parent, and author of the award-winning book The HPV Vaccine Controversy: Sex, Cancer, God and Politics (Praeger, 2008), I feel
compelled to comment on this issue.

A report presented by four different sources to the Advisory Committee on Immunization Practices (ACIP), an independent panel of experts that advises
the Centers for Disease Control and Prevention (CDC) on vaccine policies, found no signals to link Garda­sil directly to any of the serious
adverse effects that have been publicized in the media.

To clarify this and help consumers make the best-informed decision be­fore vaccinating, it is helpful to understand the difference between a side
effect (caused directly by the vaccine) and an adverse effect (which usually occurs within six weeks after the administration of a vaccine but may or
may not be related to the vaccine).

1) The most common side effects reported are pain followed by swelling and redness at the site of injection. These temporary symptoms usually resolve
within a few days, as is the case with most other vaccines.

2) The number of adverse effects that link the HPV vaccines to the nervous system disorder Guillain-Barré Syn­drome is around one to two out
of every 100,000 cases-about the same as the number of cases that occur in the general population as a sheer coincidence or chance-and such disorders
have the same statistical occurrence as the population at large that has not been vaccinated.

It is obvious that the greater the number of shots administered (as of June 22, 2011, 35 million doses of Gardasil had been distributed), the more
likely the chance for these rare and unexpected events to occur. It should be noted that there is no report from the CDC of Gardasil resulting in
mental retardation.

The HPV vaccine has established a decent track record at five years post-licensure. Based upon these current findings, the FDA strongly recommends
vaccinating the target population: nine- to twenty-six-year-old females and males. The CDC will continue to be vigilant and monitor safety data on an
ongoing basis. Nevertheless, it is helpful to remind ourselves that regardless of how well studies are conducted, gray zones of risk exist. The history
of medicine has shown us that such unfortunate events do occur for unknown reasons, and research is underway to study if genetics and environmental
factors have a role to play in such rare and serious events.

One should always balance the great­er good with these potentially minimal risks when evaluating the ad­vantages offered by new and emerging
medicines. Scaremongering for personal political gain does not bode well for the education and welfare of the public. In the case of the HPV vaccine,
it would be a shame if negative attention created by a few rare effects hampers the efforts to reach millions of women and men who risk losing their
lives to HPV-related diseases, including cancers and particularly cervical cancer, both in our country and around the world.

Shobha S. Krishnan

Shobha S. Krishnan, MD, is the founder and president of the Global Initiative Against HPV and Cervical Cancer (www.giahc.org). She is author of the international award–winning book The HPV Vaccine Controversy: Sex, Cancer, God and Politics. A family physician and gynecologist, she serves on the STD research working group at the Columbia College of Physicians and Surgeons and on the Medical Advisory Board of the National Cervical Cancer Coalition.

Content copyright CSI or the respective copyright holders. Do not redistribute without obtaining permission. Articles, reports, reviews, and letters published on the CSICOP.org website represent the views and work of individual authors. Their publication does not necessarily constitute and endorsement by CSI or its members unless so stated. Thanks to the ESO for the image of the Helix Nebula, also NASA, ESA and the Hubble Heritage Team for the image of NGC 3808B (ARP 87).